MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX MALECOT MODEL DRAIN

Model Number	086014
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that it contained the device of different hardness.It was also stated that the wrong size was incorrectly packed.
Additional Manufacturer Narrative
The reported event was unconfirmed since the product meets specifications.Three unopened malecots were returned in their original packaging all three malecots were measured and were found to be 14 french meet specifications.As the french size was found to be 14 french for all three catheters, there does not appear to be a relationship between the reported event and the device.The device history record review was not required as the reported event was unconfirmed.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that it contained the device of different hardness.It was also stated that the wrong size was incorrectly packed.

• Brand Name: BARDEX MALECOT MODEL DRAIN
• Common Device Name: MALECOT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10600515
• Report Number: 1018233-2020-06242
• Device Sequence Number: 14104642
• Product Code: FEW
• UDI-Device Identifier: 00801741023835
• UDI-Public: (01)00801741023835
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 086014
• Device Catalogue Number: 086014
• Device Lot Number: NGDX4162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1